MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-004

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The patient was revised to address loosening of the tibial component at the cement to implant interface.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Medical records received were reviewed by a clinician to identify product issues and/or patient harms.Doi: 1(b)(6) 2014.Patient received a primary attune total knee replacement to treat osteoarthritis of the left knee.The patella was resurfaced, and unknown cement was utilized.The procedure was completed without complications.Dor: (b)(6) 2018.Patient referred for a revision of the left knee due to asymptomatic tibial baseplate loosening with tibial stress shielding.Upon entering the knee, the surgeon confirmed identified loosening of the tibial tray at the cement to implant interface.The tibial tray was subsided and completely debonded from the cement.The femoral component and patella were well-fixed and retained.There was no reported problem with the revised tibial insert.The patient was implanted with depuy revision knee components utilizing competitor cement.

Event Description

On (b)(6) 2020, the patient underwent a second left knee revision due to pain.The femoral and patellar components were well-fixed and retained.Pre-operatively the surgeon noted he suspected possible tibial tray loosening and osteolysis, however, he indicated within the note the tibial tray was not loose and there was no mention of osteolysis.Competitor cement was used during the first revision.The products implanted during the first revision on (b)(6) 2018 are found on page 10 of the attached medical records from 27 feb 2020.A task has been created to create a new pc to capture the second revision.Doi: (b)(6) 2018.Dor: (b)(6) 2020.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8244251
• MDR Text Key: 132938970
• Report Number: 1818910-2019-80770
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 5462502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 5 8MM; ATTUNE PS FEM LT SZ 5 NAR CEM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR